HEMORRHOIDAL- mineral oil,petrolatum,phenylephrine ointment 
Valu Merchandisers, Co.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Best Choice Hemorrhoidal Ointment

Uses

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression.

When using this product

do not exceed the recommended daily dosage unless directed by a doctor.

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into the rectum causes additional pain

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Other information

Store at 20 o to 25 oC (68 o to 77 oF)

Inactive ingredients

beeswax, benzoic acid, BHT, cocoa butter, cod liver oil, glycerin, lanolin, methylparaben, paraffin, propylparaben, purified water, squalane, thyme oil, tocopherol acetate

Active ingredients

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Protectant

Vasoconstrictor


Package label

Best Choice Hemorrhoidal Ointment image of carton label

HEMORRHOIDAL 
mineral oil,petrolatum,phenylephrine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM71.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
APIS MELLIFERA (UNII: 7S82P3R43Z)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
COCOA BUTTER (UNII: 512OYT1CRR)  
COD LIVER OIL (UNII: BBL281NWFG)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SQUALENE (UNII: 7QWM220FJH)  
THYME OIL (UNII: 2UK410MY6B)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-161-021 in 1 CARTON05/30/2018
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/06/2012
Labeler - Valu Merchandisers, Co. (868703513)

Revised: 5/2018
Document Id: 6d88ac6a-2130-cf1c-e053-2991aa0a4654
Set id: 80bb0c90-fd5f-45e9-a85c-0d586f70ee86
Version: 2
Effective Time: 20180531
 
Valu Merchandisers, Co.